A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)

INTERVENTION: Patients will be randomly assigned to one of four regimens in the ratio 2:1:2:1, as follows: 1. THC (Marinol) (maximum total daily dose 0.25 mg/kg in equal doses, given as 2.5 mg THC capsules) 2. Placebo capsules (containing oil vehicle) matched to appearance of THC 3. Natural cannabis oil (Cannador) containing the same dose of THC, made up to GMP standard 4. Placebo capsules (containing oil vehicle) matched to appearance of the cannabis capsules CONDITION: Multiple sclerosis ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: Changes in Ashworth score SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Clinically definite or laboratory supported MS aged 18‐64 years inclusive 2. Significant spasticity in at least 2 lower limb muscle groups (Ashworth score of 2 or more, in two or more muscle groups, eg left foot plantar flexion & left knee & right knee flexors, etc) 3. Stable disease for previous 6 months in the opinion of the treating physician 4. Antispasticity medication and physiotherapy stabilised for the last 30 days 5. Patients may be ambulatory or not